Brain Myelination Effects of Paliperidone Palmitate Versus Oral Risperidone in First Episode Schizophrenia

Schizophrenia Clinical Trial

Official title: Brain Myelination Effects of Paliperidone Palmitate vs. Oral Risperidone in First Episode Schizophrenia

Status Not yet recruiting

Clinical Trial Summary

This study will determine the effects on brain myelination and cognition of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in first-episode schizophrenia subjects. The hypothesis being tested is that continual inhibition of enzymes such as glycogen synthetase kinase 3 provided by injectable paliperidone palmitate will promote myelination to a greater extent than oral risperidone.

Clinical Trial Description

Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer extrapyramidal side effects than older "typical" antipsychotics. Oral risperidone is an atypical antipsychotic medication that is very commonly used to control the symptoms of schizophrenia. Adherence to prescribed oral medication continues to be a major clinical issue.

This study will determine the effectiveness of oral risperidone versus a long-acting injectable alternative, paliperidone palmitate, in improving brain myelination and cognitive function in people with first-episode schizophrenia. Impact on brain myelination and clinical symptoms will be examined to test the hypothesis that brain myelination changes underlie one of the mechanisms of action of antipsychotics. This study will assess biomarkers at baseline (pre randomization), 6 months, and end of "parent study" participation.

Participants in the "parent" open label study will be randomly assigned to receive either orally administered risperidone or long-acting paliperidone palmitate administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of paliperidone palmitate once every 4 weeks. Dosages will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient oral risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Parent study visits will occur once weekly throughout the study. They will include psychiatrist monitoring of medication response and side effects; group therapy meetings focused on everyday living skills; family education about schizophrenia; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms, work recovery, and social functioning. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT01458379
• Study type: Interventional
• Source: University of California, Los Angeles
• Contact: George Bartzokis, M.D.
• Phone: 310-206-3207
• Email: gbar@ucla.edu
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2012
• Completion date: December 2015